BEUDAMED
    FDA Enforcement Class II Terminated

    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

    Recall: Z-1638-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1638-2016
    Event ID
    73578
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ascom US, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    December 10, 2015
    Classification Date
    May 10, 2016
    Termination Date
    October 13, 2017
    Address
    300 Perimeter Park Dr Ste D, N/A, Morrisville, NC, 27560-9703, United States

    Description

    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

    Reason

    Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.

    Code Info

    Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0

    Distribution

    CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.

    Quantity

    319